Date Published: June 10, 2019
Publisher: Public Library of Science
Author(s): Phiona Marongwe, Paidamoyo Gonouya, Thoko Madoda, Vernon Murenje, Mufuta Tshimanga, Shirish Balachandra, John Mandisarisa, Vuyelwa Sidile-Chitimbire, Sinokuthemba Xaba, Batsirai Makunike-Chikwinya, Marrianne Holec, Scott Barnhart, Caryl Feldacker, Joseph K.B. Matovu.
Ensuring quality service provision is fundamental to ZAZIC’s voluntary medical male circumcision (MC) program in Zimbabwe. From October, 2014 to September, 2017, ZAZIC conducted 205,847 MCs. Passive surveillance recorded a combined moderate and severe adverse event (AE) rate of 0.3%; reported adherence to follow-up was 95%, suggesting program safety. Despite encouraging passive surveillance data, verification of data quality and accuracy would increase confidence in AE identification.
From May to August, 2017, ZAZIC implemented a focused quality assurance (QA) study on AE ascertainment and documentation at 6 purposively-selected, high-volume MC sites. ZAZIC Gold-Standard (GS) clinicians prospectively observed 100 post-MC follow-ups per site in tandem with facility-based MC providers to confirm and characterize AEs, providing mentoring in AE management when needed. GS clinicians also retrospectively reviewed site-based, routine MC data, comparing recorded to reported AEs, and held brief qualitative interviews with site leadership on AE-related issues.
Observed AE rates varied from 1–8%, potentially translating to thousands of unidentified AEs if observed AE rates were applied to previous MC performance. Most observed AEs were infections among younger clients. Retrospective review found discrepancies in AE documentation and reporting. Interviews suggest human resource and transport issues challenge MC follow-up visit attendance. Post-operative self-care appears to produce generally good results for adults; however, younger clients and guardians need additional attention to ensure quality care. There was no evidence of missed severe AEs resulting in permanent impairment or morbidity.
Although results cannot be generalized, active surveillance suggests that AEs may be higher and follow-up lower than reported. In response, ZAZIC’s Quality Assurance Task Force will replicate this QA study in other sites; increase training in AE identification, management, and documentation for clinical and data teams; and improve post-operative counseling for younger clients. Additional nurses and vehicles, especially in rural health clinics, could be beneficial.
Accurate, timely, and reliable public health data are essential for the delivery of high-quality healthcare services. In voluntary medical male circumcision (MC) programs, a key indicator of program quality is the rate of adverse events (AEs). AEs in clinical MC settings are uncommon with few mortalities . After clinical trials in sub-Saharan Africa demonstrated that MC was safe [3–5], an AE rate of 2% moderate or severe AEs became a commonly-used standard for safety [6, 7]. In general, severe AEs are those requiring surgical intervention or hospitalization, whereas any AE not classified as severe, but which requires intervention by a health care provider or medication, is considered moderate [8, 9]. AEs are also categorized by type, e.g. infection, bleeding, etc. . AE rates may be higher in MC programs operating at scale without the clinical oversight and control of research studies. Although AE reporting definitions may differ slightly, field settings with active surveillance (proactive patient follow-up) often report higher AE rates, varying from 7% [10, 11] to nearly 18% . In contrast, passive surveillance settings (typically routine care settings without added proactive patient tracing) rely predominantly on clients presenting at a health facility. AE rates from passive surveillance in sub-Saharan Africa report lower AE rates, beneath the 2.0% threshold [13, 14]. In countries and settings with severe healthcare shortages and fewer resources, including Zimbabwe , passive surveillance may be weak .
ZAZIC implemented a mixed-method, quality assurance activity in 6 purposively selected, high-volume MC sites. In contrast to reported moderate/severe AE rates ranging from 0.1%-0.6%, AE rates of 1.0–8.0% were observed through prospective, tandem, post-operative MC reviews. Retrospective record review and site interviews confirm AE data discrepancies and weaknesses in AE reporting and documentation. Although these findings are not generalizable nor definitive, they are highly suggestive that actual AE rates are higher than reported AE rates, decreasing confidence in the reliability and validity of routine AE identification and reporting. It is unlikely that this phenomenon is unique to the study sites or to ZAZIC. Significant underreporting of AEs is likely in other MC programs at scale. Despite raising concerns, there was no evidence of missed severe AEs resulting in permanent impairment or morbidity. We discuss several lessons learned and next steps to help ensure continuous quality improvement for both data quality and patient safety.
Reported AE rates collected through passive surveillance appear low. In contrast, the active surveillance employed through this QA study found that observed AE rates are considerably higher while record review found that AE data quality is sub-optimal. It is unlikely that this phenomenon is unique. Although the results may not be definitive nor generalizable, they require follow-up action. ZAZIC promotes quality assurance and patient safety as critical components of its MC implementation. Therefore, to meet the study objectives of strengthening AE documentation and increase confidence in AE data quality, there were several quality assurance activities implemented to address the study findings.